Menopause is the termination of the menstrual cycle in woman, and is caused by the changes in hormone levels that occur naturally over time. Estrogen and progesterone are the key hormones involved in these changes, but other factors may be involved as well.
The onset of menopause is associated with many symptoms will vary between women, but will generally include one or more of the following symptoms: hot flashes, numbness, tingling, insomnia, nervousness, depression, vertigo, fatigue, arthralgia, myalgia, headaches, palpitations, and formication. Osteoporosis is another condition associated with the onset of menopause, and leads to decreased bone density and an increase in fractures and breaks.
Menopausal symptoms are related primarily to the change in estrogen levels, and estrogen replacement therapy, either with or without progesterone, is a common method of providing some relief from menopausal symptoms. However, hormone replacement therapy is associated with many adverse effects, potentially leading to problems are potentially more troublesome than the menopausal symptoms themselves. Calcium may be added to the regimen to combat or prevent the effects of osteoporosis.
Other, methods for treating the symptoms associated with menopause are known. For instance, there are several herbal remedies that are used to alleviate menopausal symptoms; homeopathic remedies are known as well. Presently available formulations consist of either herbs or homeopathics; combination formulations of herbal and homeopathics are not presently believed to be available. One example of a commercially available homeopathic remedy for treatment of menopausal symptoms is Hyland's Menopause Tablets, which contains a specific combination of Amyl Nitrosum, Sanguinaria Canadensis and Lachesis Mutus in a lactose base. Other known homeopathic products useful in treating various conditions are described in the Homeopathic Pharmacopeia of the United States(HPUS).
Despite the advances in the art, there is a need for improved therapies for treating menopausal symptoms. Thus, it is an object of the present invention to provide improved formulations for the treatment and prevention of menopausal symptoms.
It is also an object of the present invention to provide improved methods for preparing formulations, particularly oral solid dosage forms, useful in treating menopausal symptoms.
It is also an object of the present invention to provide improved methods of treating, preventing or otherwise mitigating the symptoms associated with menopause.
These objects and others are achieved by the present invention, which related in part to an oral solid dosage form that includes from about 1 to about 99 wt. % of a therapeutically effective amount of at least one herb that renders a therapeutic effect on menopausal symptoms, and from 1 to about 99 wt. % of at least one homoeopathic component that renders a therapeutic effect on menopausal symptoms, wherein the weight percent is based on the total amount of the homeopathic and herbal components. For purposes of this invention, rendering a therapeutic effect on menopausal symptoms is defined as reducing the severity or incidence, preventing, or otherwise alleviating at least one symptom associated with menopause. In preferred embodiments, the herbal component will include Cimicifuga Racemosa, and the homeopathic component will include Amyl Nitrate. In other preferred embodiments, the oral solid dosage form provides a sustained release of one or more active components in vivo for a time period of from 6 to about 24 hours.
In a preferred embodiment, the oral solid dosage form also contains a calcium salt, e.g. calcium citrate. When calcium is present, it is preferred that at least 200 mg calcium ion be provided by the dosage form. Preferred dosage forms include tablets and capsules.
The present invention also relates to a method of preparing an oral dosage form for the treatment of menopausal symptoms. The dosage forms may be prepared by admixing the requisite amounts of homeopathic drug and herbal components, together with the calcium salt any pharmaceutical excipients, and dividing the mixture into unit doses containing an appropriate amount of the admixture to treat menopausal symptoms when administered to a patient in need of such treatment.
The present invention also relates to a method of treating menopausal symptoms by administering a unit dose of the combination of the present invention to a patient in need of treatment for menopausal symptoms.
The invention is described in more detail in the description that follows.